Phase III Study, V-15-32, of Gefitinib Versus Docetaxel in Previously Treated Japanese Patients With Non–Small-Cell Lung Cancer

Maruyama, Riichiroh; Nishiwaki, Yutaka; Tamura, Tomohide; Yamamoto, Nobuyuki; Tsuboi, Masahiro; Nakagawa, Kazuhiko; Shinkai, Tetsu; Negoro, Shunichi; Imamura, Fumio; Eguchi, Katsumi; Takeda, Koji; Inoue, Akira; Tomii, Keisuke; Harada, Masao; Masuda, Noriyuki; Jiang, Haiyi; Itoh, Yoshio; Ichinose, Yukito; Saijo, Nagahiro; Fukuoka, Masahiro

doi:10.1200/jco.2007.15.0185

Cited by 335 publications

(274 citation statements)

References 17 publications

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“…In addition, once the patients are diagnosed as not harboring sensitive EGFR mutations, physicians might not treat them with EGFR-TKIs even after the relapse of first-line chemotherapy, though second-line gefitinib was previously reported to show acceptable toxicity and efficacy for patients with NSCLC harboring EGFR-sensitive mutations. 27,28 Thus, a false negative seems to be a more severe problem for patients with NSCLC harboring EGFR-sensitive mutations.…”

Section: Discussionmentioning

confidence: 99%

Direct Comparison of 3 PCR Methods in Detecting EGFR Mutations in Patients with Advanced Non–Small-Cell Lung Cancer

Ikeda

Nakamura

Yamaguchi

et al. 2012

Clinical Lung Cancer

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Micro abstractWe compared three PCR methods (mutant-enriched PCR, PNA-LNA PCR and PCR clamp) to detect EGFR mutations in 50 patients with advanced NSCLC. Seventeen were harboring EGFR mutations, five of whom showed discrepancies between the results of different PCR methods. All five responded to gefitinib, which we consider to suggest that the discrepancies were false negatives. Clinical Practice Points• Several methods have been used to detect EGFR mutations in non-small-cell lung cancer (NSCLC): however, it is not clear which is the most suitable for use in the clinic.• We compared three PCR methods (mutant-enriched PCR, PNA-LNA PCR and PCR clamp) in 50 patients with advanced NSCLC. Seventeen of the patients were harboring EGFR mutations, five of whom showed discrepancies between the results of different PCR methods. All five patients responded to gefitinib.• We considered that all of the discrepancies might be false negatives because the patients responded to gefitinib. To clarify the reasons for the false negatives of each PCR method, and establish the clinical sensitivity and specificity of each method, a large prospective clinical trial is warranted. AbstractBackground: Epidermal growth factor receptor (EGFR) mutations are predictive of

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Section: Discussionmentioning

confidence: 99%

Direct Comparison of 3 PCR Methods in Detecting EGFR Mutations in Patients with Advanced Non–Small-Cell Lung Cancer

Ikeda

Nakamura

Yamaguchi

et al. 2012

Clinical Lung Cancer

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“…Although several phase 3 studies comparing EGFR TKIs with chemotherapy in the second-line setting have demonstrated that similar efficacy exists between EGFR TKIs and chemotherapy, to the best of our knowledge these studies were not designed to investigate the potential effect of EGFR mutational status on efficacy. 8,9,16,[20][21][22] The TAILOR (TArceva Italian Lung Optimization tRial) trial compared erlotinib with docetaxel as the second-line treatment of advanced NSCLC in patients with wild-type EGFR disease. Results of the trial demonstrated that compared with docetaxel, erlotinib was effective in patients with wild-type EGFR.…”

Section: Discussionmentioning

confidence: 99%

“…The National Cancer Institute of Canada Clinical Trials Group Study BR.21 trial reported prolonged survival with erlotinib compared with placebo (median survival, 7.9 months vs 3.7 months) in patients with advanced non-small cell lung cancer (NSCLC) after the failure of previous chemotherapy, 7 whereas in the INTEREST (IRESSA Non-small-cell lung cancer Trial Evaluating REsponse and Survival against Taxotere) study and the V-15-32 study, gefitinib was found to have noninferior survival compared with docetaxel. 8,9 Several studies have demonstrated that a high EGFR gene copy number was associated with great sensitivity and prolonged progression-free survival (PFS) among patients with NSCLC after treatment with EGFR TKIs. 7,[10][11][12][13][14] However, subsequent studies indicated that a high EGFR copy number was not associated with greater PFS when comparing EGFR TKIs versus chemotherapy.…”

Section: Introductionmentioning

confidence: 99%

A randomized phase 2 trial of erlotinib versus pemetrexed as second‐line therapy in the treatment of patients with advanced EGFR wild‐type and EGFR FISH‐positive lung adenocarcinoma

Yang

et al. 2014

Cancer

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BACKGROUND:The current study was undertaken to investigate the efficacy and safety of erlotinib versus pemetrexed as secondline therapy for patients with advanced epidermal growth factor receptor (EGFR) wild-type and EGFR fluorescence in situ hybridization (FISH)-positive lung adenocarcinoma. METHODS: In this open-label, randomized, phase 2 study, patients with EGFR wild-type and EGFR FISH-positive adenocarcinoma who had developed disease progression after 1 prior platinum-based chemotherapy were randomly assigned (1:1) to receive erlotinib or pemetrexed until the time of disease progression or death, unacceptable toxicity, or a request for discontinuation by the patient. The primary endpoint was progression-free survival (PFS). RESULTS: A total of 123 patients were enrolled (61 in the erlotinib arm and 62 in the pemetrexed arm). The median PFS was 4.1 months (95% confidence interval [95% CI], 1.6 months-6.6 months) in the erlotinib group versus 3.9 months (95% CI, 2.7 months-5.1 months) in the pemetrexed group. The difference in PFS between the 2 treatment groups was not significant (hazard ratio, 0.92; 95% CI, 0.62-1.37 [P 5.683]). The objective response rate appeared to be higher among patients receiving erlotinib compared with those receiving pemetrexed (19.7% vs 8.1%; P 5.062). The 3 most commonly recorded adverse events were rash (54.1%), fatigue (19.7%), and diarrhea (16.4%) in the erlotinib group and fatigue (25.8%), nausea (24.2%), and anorexia (14.5%) in the pemetrexed group. CONCLUSIONS: There were no significant differences noted with regard to efficacy between erlotinib and pemetrexed in the second-line setting for patients with advanced EGFR wild-type and EGFR FISH-positive lung adenocarcinoma. Both regimens appear to be effective treatment options for these patients. Cancer 2014;120:1379-86.

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“…In this study, we evaluated the prognosis of elderly patients with NSCLC treated with second-line chemotherapy. The previous trials of docetaxel as second-line chemotherapy in younger patients with NSCLC showed that median PFS and OS were 2.8-3.2 months and 6.0-14.8 months, respectively [8][9][10][11][12][13][14][15]. In this study, there was no statistically significant difference in PFS and OS at the second-line chemotherapy between the age ≥ 75 group and the age 70-74 group.…”

Section: Discussionmentioning

confidence: 36%

“…ORR of the second-line chemotherapy was 9.2% [95% confidence interval (CI), [4][5][6][7][8][9][10][11][12][13][14][15][16][17][18][19] in age ≥ 75 group and 12.2% (95% CI, 5-26) in age 70-74 group. There was no significance difference between the groups (p=0.75).…”

Section: Efficacymentioning

confidence: 99%

Effect of Second-Line Chemotherapy in Elderly Patients with Non-Small Cell Lung Cancer

Kobayashi¹,

Kenmotsu²,

Suzuki³

et al. 2017

Chemotherapy

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Phase III Study, V-15-32, of Gefitinib Versus Docetaxel in Previously Treated Japanese Patients With Non–Small-Cell Lung Cancer

Cited by 335 publications

References 17 publications

Direct Comparison of 3 PCR Methods in Detecting EGFR Mutations in Patients with Advanced Non–Small-Cell Lung Cancer

Direct Comparison of 3 PCR Methods in Detecting EGFR Mutations in Patients with Advanced Non–Small-Cell Lung Cancer

A randomized phase 2 trial of erlotinib versus pemetrexed as second‐line therapy in the treatment of patients with advanced EGFR wild‐type and EGFR FISH‐positive lung adenocarcinoma

Effect of Second-Line Chemotherapy in Elderly Patients with Non-Small Cell Lung Cancer

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